Colorectal cancer Colorectal cancer
Conditions
Interventions
There is no specific intervention, but patients could receive cetuximab-encorafenib as a second-line treatment.
Sponsors
Amsterdam UMC
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients of 70 years or older Histologically confirmed BRAFV600E mutated adenocarcinoma of the colorectumConfirmed metastatic disease (either by radiology or histology)
Exclusion criteria
Exclusion criteria: Second primary malignancy present A second primary malignancy 2 years prior to enrollment in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To describe the systemic treatment patterns of older BRAFV600E patients with mCRC (= 70 years of age): Type of treatmentTreatment sequenceNumber of treatment lines (from start metastatic treatment to death/last contact)Treatment duration (start and end dates per treatment line)Dose adjustments (per treatment line)Reasons for treatment discontinuationReasons for treatment switch Reasons of choice for best supportive care. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to mutation (BRAFV600E) testing relative to mCRC diagnosis and to first-line treatment for mCRC, and description of mutation testing procedures (date of test, type of test, results, turnaround time, if available).To describe patient and disease demographics and characteristicsTo describe treatment response per treatment line.To describe progression free survival (PFS) per treatment line and overall survival (OS).To describe geriatric function (G8 Geriatric Screening Tool (G8), ECOG PS score, cognitive (6-item cognitive impairment test (6-CIT) and functional status (Katz ADL & Lawton iADL) at baseline (mCRC diagnosis) and during treatment (on months 3, 6, 9 and 12).To describe quality of life (Elderly Functional Index) at baseline (mCRC diagnosis) and during treatment (on months 3, 6, 9 and 12.To describe decisional regret (using Decisional Regret Scale), as part of the shared decision process, per treatment line. To describe Overall Treatment Utility (OTU), a composite clinical outcome measure designed to quantify the effect of palliative treatments on individuals with a diagnosis of advanced or incurable cancer, per treatment line. | — |
Countries
Netherlands
Contacts
Public ContactK Versteeg
Amsterdam UMC
Outcome results
None listed